Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients

A Phase II, Randomized Double Blind Placebo-Controlled, Dose Escalating Study to Determine Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00448071

Enrollment

Registered

2007-03-15

Start date

2006-05-31

Completion date

2007-03-31

Last updated

2007-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Hypotension, Intra Dialytic Hypotension

Keywords

Hypotension, End Stage Renal Disease, Intra Dialytic Hypotension, ESRD, Blood Pressure, Dialysis

Brief summary

MTR107 effect on blood pressure throught the dialysis procedure and its ability to prevent Intra dialytic Hypotension

Detailed description

The present clinical trial aims to investigate and provide a more precise characterization of the pharmacokinetic and pharmacodynamic profile of MTR107 in a population of ESRD patients predisposed to developing intradialytic hypotension. The study is also designed as a dose esclating study aiming to assess MTR107 safety.

Interventions

DRUGMTR107

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Age 20-75 years, inclusive. 2. Presence of frequent bouts of hypotension defined as 3 or more intradialytic hypotensive events per month for the last six months prior to baseline, despite standard adjustments in dry weight. 3. ECG performed up to one month before study start. 4. Well-preserved hepatic function (within normal laboratory ranges) at study entry as judged by: * Serum Bilirubin (Total Bilirubin (direct and indirect) 0.3-1.0 mg/dL, and Direct Bilirubin 0.1-0.5 mg/dL) * Serum Albumin (\>3.6 g/dL), * Serum aminotransferases (AST (0-37 U/L) and ALT (0-40 U/L)), * GGT (Gamma Glutamine Trans Peptidase) 5. Normal coagulation status at study entry as judged by PT-INR, PTT, fibrinogen and platelet count. 6. Willingness to participate in the study and adhere to the study design. 7. Willingness to sign an informed consent form.

Exclusion criteria

1. Uncontrolled hypertension \>140/90 mmHg. 2. Unstable angina. 3. Abnormal ECG which may indicate acute disease 4. Variable weight gains. 5. Mental retardation. 6. Pregnancy. 7. Malignancy or other concomitant serious diseases. 8. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days.

Design outcomes

Primary

Measure	Time frame
A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.	—

Secondary

Measure	Time frame
Exploratory Efficacy Parameters:	—
 Number and type of medical interventions required for treatment of hypotension.	—
 Alleviation of symptoms associated with intradialytic hypotension.	—
 Efficiency of dialysis as reflected by Kt/V	—

Countries

Israel

Contacts

Primary ContactZeev Katzir, MD

972-3-5028211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026